China Fund News reporter Lu Yuan
Many leading Chinese medicine companies are expanding their business layout into non-Chinese medicine fields.
Yunnan Baiyao announced on the evening of June 28 that the company intends to introduce relevant patents for the antibody drug KA-1641, and will carry out research and development, production and commercialization activities for the product worldwide.
A few days ago, Pien Tze Huang, which ranks first in the market value of A-share traditional Chinese medicine, also announced that the company has received the "Drug Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administration for PZH2113 capsules, which is a Class 1 innovative chemical drug with independent intellectual property rights of Pien Tze Huang.
It is planned to introduce monoclonal antibody patents
Yunnan Baiyao announced on the evening of June 28 that the company intends to introduce relevant patents for the antibody drug KA-1641 from Kangyuan Borche Biotechnology (Beijing) Co., Ltd.
According to the Technology Transfer Agreement signed between Yunnan Baiyao and Kangyuan Borche, Kangyuan Borche will transfer its self-developed antibody drug KA-1641 related patents to Yunnan Baiyao, with an initial payment of RMB 6 million and a R&D and registration milestone payment of RMB 32 million.
Yunnan Baiyao will carry out R&D, production and commercialization activities for the target product on a global scale, and the two parties intend to continue to jointly promote the research and development of the project on the basis of the current R&D, and eventually realize the registration and commercialization of related drugs.
In addition to the down payment and milestone payment, Yunnan Baiyao is also required to pay a sales commission and overseas licensing revenue sharing.
During the sales commission period, Yunnan Baiyao shall pay the sales commission to Kangyuan Borchuang at the agreed sales commission rate based on the annual net sales of the target products of Yunnan Baiyao, Yunnan Baiyao's affiliates and licensees in the target area in each calendar year.
If Yunnan Baiyao grants a license under the transferred technology to any third party for the purpose of developing and commercializing the target molecule and the target product in a target territory other than China, Yunnan Baiyao shall share with Kangyuan Borche the upfront payment and milestone payments actually received by Yunnan Baiyao from such third party pursuant to its relevant license agreement with such third party in accordance with the proportion agreed in the agreement.
In addition, Yunnan Baiyao will also sign a tripartite agreement with Beijing Zhao Derivatives Technology Co., Ltd. and Kangyuan Bochuang, under which Zhao Derivatives will be responsible for production and direct supply as a pharmaceutical contract customized R&D and production institution.
According to the data, KA-1641 is a monoclonal antibody drug obtained by Kangyuan Borche through hybridoma self-screening, and the relevant patents are already in the substantive examination stage. At present, the drug is in the preclinical production process research and development stage, and the preferred indication is tumor cachexia.
The nuclear drug pipeline has been fully laid out
Contrary to the general impression of the public, as a leader in traditional Chinese medicine, innovative drugs in the field of non-traditional Chinese medicine are also one of the important areas of Yunnan Baiyao's R&D planning.
In Yunnan Baiyao's view, the introduction of the above-mentioned antibody drugs will help enrich Yunnan Baiyao's innovative drug R&D pipeline, and create synergies with nuclear drugs and other products in the field of oncology, which is conducive to opening up the R&D chain from preclinical R&D to clinical research of antibody drugs, and can also accumulate experience and lay the foundation for subsequent self-development or the introduction of other innovative drugs.
The so-called "nuclear medicine", also known as radiopharmaceuticals and nuclide drugs, refers to a special class of drugs containing radionuclides for medical diagnosis and treatment. With the development of nuclear medicine, the size of China's radiopharmaceutical market has ushered in rapid growth after 2021 and is expected to continue to maintain a rapid growth trend in the next 10 years, and will further expand to 26 billion yuan in 2030.
According to Yunnan Baiyao's 2023 annual report, the company has long focused on the transformation of innovative drug R&D achievements. On the other hand, with the development of nuclear drugs as the center, a number of innovative drug development has been laid out.
In 2023, Yunnan Baiyao's nuclear drug pipeline will be fully laid out and phased results will be achieved:
The INR101 project, an innovative nuclear drug for the diagnosis of prostate cancer, has completed the pilot study and GMP production of the precursor, and received the notice of acceptance of the clinical trial for the registration of INR01 injection for domestic production of INR01 injection issued by the State Food and Drug Administration in February 2024.
The INR102 project, an innovative nuclear drug for the treatment of prostate cancer, has completed the efficacy evaluation and tissue distribution study of model animals, the production of precursors non-GMP and the process pilot study of radioactive preparations, and started pharmaceutical research.
The INR202 and INR203 programs have initiated nanobody candidate screening studies.
At the beginning of January 2024, Yunhe Pharmaceutical (Tianjin) Co., Ltd. obtained the approval of the environmental impact report form of the Tianjin project of the Nuclear Drug R&D Center (new use and sale of radiopharmaceuticals), and officially started the construction of the project. On the basis of introducing the research results of experts from the Department of Nuclear Medicine of Peking University, Yunnan Baiyao has in-depth communication or formed strategic cooperative relations with relevant departments, enterprises and hospitals in the nuclear medicine industry cluster, further improving the layout of the upstream, midstream and downstream of the nuclear medicine industry chain.
Traditional Chinese medicine leaders have been laid out
In addition to Yunnan Baiyao, other leading Chinese medicine companies are also deploying innovative drug research and development to varying degrees.
Pien Tze Huang, which ranks first in the market value of the A-share traditional Chinese medicine sector, announced on the evening of June 20 that the company has received the "Drug Clinical Trial Approval Notice" for PZH2113 capsules approved and issued by the State Food and Drug Administration.
PZH2113 Capsule is a Class 1 innovative chemical drug with independent intellectual property rights of Pien Tze Huang, which is intended for the treatment of relapsed/refractory non-Hodgkin lymphoma dominated by diffuse large B-cell lymphoma (DLBCL). As of the announcement date, the cumulative R&D investment of the drug project is about 39 million yuan (unaudited).
As early as August 2020, Pien Tze Huang's first chemical class 1 innovative drug PZH2111 tablets independently developed was approved by the State Food and Drug Administration to carry out clinical trials, mainly for the treatment of advanced solid tumors such as intrahepatic cholangiocarcinoma and urothelial cell carcinoma with FGFR gene alterations.
Up to now, in the field of chemical drugs, including cooperative products, Pien Tze Huang has 4 Class 1 new drugs in the clinical trial stage, and 2 innovative chemical drugs are in the preclinical research stage, involving tumors, pain, psychiatric nerves and other subdivided treatment fields.
In addition, Tasly, Yiling Pharmaceutical, and China Resources Sanjiu are also extending and expanding into the field of chemical and biological drugs.
According to the annual report, Tasly currently has a R&D pipeline covering 98 products under development, including 41 Class 1 innovative drugs, of which 36 are in clinical trials and 26 are in phase II and III clinical trials.
Yiling Pharmaceutical adheres to the development strategy of "transfer and processing, entry - international and domestic dual registration of generic drugs - R&D, production and sales of patented new drugs" in the chemical and biological drugs sector, and uses Ling Wanzhou as the operation platform of its chemical and biological drugs sector through the establishment of a wholly-owned subsidiary. Up to now, Yiling Pharmaceutical has 4 Category 1 innovative drugs entering the clinical stage, and a number of Category 1 innovative drugs are in the preclinical research stage.
CR Sanjiu also has three Class 1 new chemical drugs under development, all of which are currently in the phase I clinical research stage.
Editor: Xiao Mo
Review: Muyu